Subject-Matter Eligibility In The Wake of Mayo v. Prometheus - Robert M. Schulman David A. Kelly
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Subject-Matter Eligibility In The
Wake of Mayo v. Prometheus
April 2012
Robert M. Schulman
David A. KellyMayo v. Prometheus
In Mayo Clinic v. Prometheus Labs., a unanimous
Supreme Court struck down medical treatment claims as
directed to a law of nature and thus patent ineligible.
Claim 1 is representative:
A “method of optimizing therapeutic efficacy for treatment” of an
immune-mediated GI disorder, comprising:
(a) “administering” to a subject having a GI disorder a drug that
provides 6-TG; and
(b) “determining” the level of 6-TG in the subject;
wherein the measured level of 6-TG “indicates a need” to
increase or decrease the amount of drug subsequently
administered to the subject.
2Mayo v. Prometheus
The Supreme Court was the final stop in a long and
tumultuous journey for these method claims:
– In 2004, Prometheus sued Mayo over its diagnostic tests embodying the
claimed methods;
– District court granted summary judgment of invalidity under § 101, holding the
patents claimed correlations that were natural phenomena;
– Federal Circuit reversed, holding the claims met the MOT test since
“administering” and “determining” were transformative and not merely data-
gathering.
– Supreme Court vacated and remanded for reconsideration in light of Bilski.
– On remand, Federal Circuit affirmed its earlier decision, again relying on the
MOT test and holding that “methods of treatment … are always transformative
when one of a defined group of drugs is administered to the body to
ameliorate the effects of an undesired condition.”
3Mayo v. Prometheus
Question Presented:
The question before us is whether the claims do
significantly more than simply describe … natural
relations. To put the matter more precisely, do the
patent claims ad enough to their statements of the
correlations to allow the processes they describe to
qualify as patent-eligible processes that apply
natural laws. We believe that the answer to this
question is no.
4Mayo v. Prometheus
The Court rejected the Federal Circuit’s reliance on the
MOT test and struck down the claims as directed to
patent-ineligible laws of nature:
– The MOT test is “an important useful clue” to patentability, but cannot
trump the “law of nature” exclusion.
– Because the recited laws of nature—correlations between metabolite
concentration and drug effectiveness—are not themselves patent-
eligible, the claimed process likewise fails unless it has “additional
features that provide practical assurances that the process is more
than a drafting effort designed to monopolize the law of nature itself.”
– While it takes a human action (administering the drug) to trigger the
correlation, that correlation exists apart from any human action; it is a
consequence of how the body naturally metabolizes the drug.
5Mayo v. Prometheus
The Court articulated an “inventive concept” test of patent-
eligibility, in which the claim recite “significantly more” than
the natural law:
– Methods that depend on natural laws must “contain other elements or a
combination of elements, sometimes referred to as an ‘inventive
concept,’ sufficient to ensure that the patent in practice amounts to
significantly more than a patent upon the natural law itself.”
– Here, the claimed “additional” steps consisted of “well-understood,
routine, conventional activity already engaged in by the scientific
community,” and thus failed the “inventive concept” test.
– The Court distinguished Prometheus’ claims, which do not confine their
reach to particular applications of natural laws, from “a typical patent on
a new drug or a new way of using an existing drug.”
6Mayo v. Prometheus
The Court feebly distinguished its 1981 Diehr decision:
– The claimed method in Diehr (held to be patent eligible) recited a
method for molding rubber using the Arrhenius equation to determine
when, based on temperature, to open the molding press.
[Diehr] nowhere suggested that all these steps, or at least the combination
of those steps, were in context obvious, already in use, or purely
conventional. … These other steps apparently added to the formula
something that in terms of patent law’s objectives had significance—they
transformed the process into an inventive application of the formula.
– According to the Court, Prometheus’ claims, by contrast, merely pick
out the relevant audience (doctors) and tell them to apply the
unpatentable law of nature when treating their patients: “The process in
Diehr was not so characterized.”
7Mayo v. Prometheus
The Court declined to address the broader implications of
its decision raised by the amicus briefs:
– Rejecting the government’s argument that sections 112, 102, and
103 were adequate to address the Court’s concerns of impeding
future innovation, the Court reasoned that this “risks creating
greater legal uncertainty, while assuming those sections can do the
work that they are not equipped to do.”
– The Court concluded its opinion by noting that it “need not
determine here whether, from a policy perspective, increased
protection for discoveries of diagnostic laws of nature is desirable.”
That’s the job of Congress.
8PTO Response
The PTO recently issued a memo “to provide preliminary
guidance” on section 101 in the wake of Mayo:
– Reminds examiners that the MOT test “is an investigative tool, it is
not the sole or a determinative test for deciding whether an
invention is patent-eligible.”
– “[T]o be patent-eligible, a claim . . . should include other elements
or combinations of elements such that, in practice, the claimed
product or process amounts to significantly more than a law of
nature, a natural phenomenon, or an abstract idea with
conventional steps specified at a high level of generality appended
thereto.”
9AMP v. Myriad
In the wake of Mayo, the Supreme Court set aside the
Federal Circuit’s decision in AMP v. Myriad, remanding
the case for further consideration:
– In Myriad, the Federal Circuit struck down a method of determining
cancer predisposition by “analyzing” or “comparing” different gene
sequences. But the court affirmed the patent-eligibility of:
(1) “isolated DNA” claims; and
(2) a method of screening potential cancer therapeutics comprising
“comparing” and “determining” the growth rates of cells transformed
with different gene sequences.
– On remand, the Federal Circuit will likely uphold at least some of
the DNA claims of (1) but may strike down the method claim of (2).
10AMP v. Myriad
Myriad’s imperiled method claim recites:
A method for screening potential cancer therapeutics
comprising:
(a) “growing” host cells transformed with an altered BRCA1
gene in the presence or absence of a potential cancer
therapeutic,
(b) “determining” the growth rate of the host cells with or
without the potential therapeutic, and
(c) “comparing” the growth rate of the host cells.
– It’s questionable whether this claim survives in view of Mayo’s
proscription against claims that rely on natural laws and recite
mere conventional steps. Myriad might argue that step (a) of the
claim recites a novel and active step.
11Classen v. Biogen
Mayo now also calls into question the viability of the
Federal Circuit’s holding in Classen v. Biogen:
– In Classen, the Federal Circuit court struck down a method whereby
mammals having a disorder are “immunized” according to a schedule, and
the severity of the disorder is “compared” to a control group. But the court
upheld a method whereby information on immunization schedules is
“screened” and “compared,” the lower risk schedule is ”identified,” and
subjects are “immunized” according to that schedule.
– The distinction the court drew was that the second method recited the
physical step of immunizing subjects and thus were directed to a specific,
tangible application, whereas the first method only recited the step of
immunization for gathering information and comparing results.
– It’s unclear whether, post-Mayo, the second method in Classen would still
survive section 101 scrutiny. One possible distinction is that it is a
therapeutic claim, rather than a diagnostic claim.
12Claims Drafting Tips
1. Satisfying the MOT test is not enough!
2. Style the claims as therapeutic methods, not diagnostic methods:
• Not this: “A method of diagnosing a patient having disease X comprising
measuring the level of expression of gene Y, comparing that expression to a
control, wherein overexpression of gene Y is indicative of a need to
administer drug Z.”
• But this: “A method for treating a patient having disease X comprising
administering drug Y in a concentration optimized for that patient based on a
prior diagnostic test.”
• Or this: “A method for treating a patient having disease X comprising
administering drug Y in a concentration that yields no more than 100 pmol
per 8x108 of metabolite Z.”
• Or this: “A method for treating a patient having disease X comprising
determining the expression profile of gene Y, comparing that expression with
a reference expression profile, and administering a therapeutically effective
amount of drug Z based on said gene Y expression profile.
13Claims Drafting Tips
• Diagnostic claims are harder to disentangle from the natural law
underlying the diagnosis because the diagnosis is typically based
on a result (e.g., gene expression, metabolite levels, etc.) that is
driven entirely by how the patient’s body functions (e.g.,
expression a gene or metabolizes a protein).
• Therapeutic claims, on the contrary, have the advantage of
applying diagnostic information (e.g., treat disease X based on
gene expression profile) instead of simply gathering it.
14Claims Drafting Tips
3. Include “unconventional” steps that confine the invention to a
particular, useful application of the principle, i.e., where:
• What’s being administered is novel (e.g., a novel drug or
combination of drugs, a novel dosage concentration)
• What’s being detected is novel (e.g., a newly discovered
biomarker, isolated metabolite);
• The relationship between what’s being detected and the
disease is novel (e.g., previously unknown correlation between
gene X and disease Y); or
• The method by which the drug is being administered or
detected is novel (e.g., a novel drug dosage form, a novel
detection assay)
15Claims Drafting Tips
4. Consider claiming some features more narrowly in order to clarify
the “inventive concept”, e.g., where the invention rests in part on:
• The nature of the sample (e.g., the test works better with urine
samples than blood samples);
• The nature of the detection technique (e.g., gene expression is
superior to protein expression).
16Joint Infringement Issues
• As biotech patentees figure out how redraft their claims to satisfy
Mayo, they are increasingly likely to encounter thorny issues of
joint and indirect infringement.
• Presently, these very issues are being reviewed by the Federal
Circuit sitting en banc:
– Akamai Technologies v. Limelight Networks (2010)
– McKesson Technologies v. Epic Systems (2011)
• The panels in Akamai and McKesson held that joint infringement
of a method claim requires an agency relationship between the
accused joint infringers.
17Joint Infringement Issues
• The issues on appeal are:
1. If separate entities each perform separate steps of a method claim,
under what circumstances would that claim be directly infringed and
to what extent would each of the parties be liable? (Akamai)
2. If separate entities each perform separate steps of a method claim,
under what circumstances, if any, would either entity or any third
party be liable for inducing infringement or for contributory
infringement? (McKesson)
3. Does the nature of the relationship between the relevant actors—
e.g., service provider/user; doctor/patient—affect the question of
direct or indirect infringement liability? (McKesson)
18Joint Infringement Issues
• Oral argument was held on November 18, 2011:
– Pointing to common law principles of joint liability, Akamai argued
that when multiple parties perform the steps of a method claim,
there is direct infringement if: (1) one party directs or controls the
other; (2) the parties act in concert; or (3) one of the parties has
knowledge that all the steps are being performed.
– Pointing to the Patent Act, Limelight and Epic argued that joint
infringement liability was strictly limited to indirect forms of
infringement (i.e., inducement and contributory infringement).
19Joint Infringement Issues
• If the Court loosens the standard for establishing infringement
liability when multiple parties act in concert—as Akamai and
McKesson are urging—therapeutic claims reciting multiple steps
be performed by multiple actors (e.g., doctor, outside laboratory,
etc.) should be easier to enforce.
• But if the Court holds that joint infringement requires an agency
relationship between the actors, therapeutic claims will be
susceptible to circumvention by multiple actors performing
different steps independently of one another.
20Thank You! David A. Kelly Robert M. Schulman Hunton & Williams, LLP Hunton & Williams, LLP 600 Peachtree St., N.E. 2200 Pennsylvania Av. Atlanta, GA 30308 Washington, DC 20037 Phone (404) 888-4280 Phone (202) 955-1500 Fax (404) 888-4190 Fax (202) 778-2201
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